MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK ADVANCER; CATHETER, CORONARY, ATHERECTOMY

Model Number	3280
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter information: (b)(6).
Event or Problem Description
It was reported that the procedure was cancelled.The 75% stenosed, 18mmx3.5mm target lesion was in the moderately tortuous and severely calcified left anterior descending artery.A rotalink advancer was selected for use.During the procedure, it was noted that the device could not start and stalled.The procedure could not continue.No patient complications reported and the patient was stable post procedure.
Event or Problem Description
It was reported that the procedure was cancelled.The 75% stenosed, 18mmx3.5mm target lesion was in the moderately tortuous and severely calcified left anterior descending artery.A rotalink advancer was selected for use.During the procedure, it was noted that the device could not start and stalled.The procedure could not continue.No patient complications reported and the patient was stable post procedure.It was further reported that after the device was replaced, the issue remained, so the rotational atherectomy was stopped.The procedure was completed by using post-dilation balloon and cutting balloon under high pressure.The patient was under local anesthesia.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital e1 - initial reporter address 1: (b)(6).H6 code corrected.
Event or Problem Description
It was reported that the procedure was cancelled.The 75% stenosed, 18mmx3.5mm target lesion was in the moderately tortuous and severely calcified left anterior descending artery.A rotalink advancer was selected for use.During the procedure, it was noted that the device could not start and stalled.The procedure could not continue.No patient complications reported and the patient was stable post procedure.It was further reported that after the device was replaced, the issue remained, so the rotational atherectomy was stopped.The procedure was completed by using post-dilation balloon and cutting balloon under high pressure.The patient was under local anesthesia.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Returned product consisted of the rotablator rotalink advancer.Inspection of the device did not identify any damages or defects.During destructive testing, inspection revealed that the fiber optic cable to the advancer was found detached.Because the cable was set into the turbine housing upon device return, the detachment was unnoticed as the clear prongs within the connection point were holding the cable in place but was found to be loose during destructive testing.Additionally, the turbine was corroded, indicating the presence of dried saline within the device.It was considered likely that the presence of dried saline interfered with the device's ability to rotate during analysis leading to a device stall.The advancer was connected to the rotablator console control system.When the foot pedal was pushed, the device stalled and would not run.In order to determine the cause for the device stall, destructive testing was performed, in which the advancer was dismantled.During destructive testing, the fiber optic cable detachment was viewed under the microscope.Damage was found to the connecting end of the cable had sharp marks indicating a user interaction or tampering at the connection point.The detached ends were jagged indicating the cable connection was broken apart with force.After destructive testing was performed, it was found that the shutter was damaged.The damage present could lead to fiberoptic interference.Design assurance and cork supplier quality were contacted, and it was verified that the shutter damage present was likely due to a molding defect from supplier.Photo media depicted outer box packaging to the reported complaint device; however, the reported event could not be confirmed with the media provided.

• Brand Name: ROTALINK ADVANCER
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19610426
• Report Number: 2124215-2024-38996
• Device Sequence Number: 8485795
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: 08714729317739
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2025
• Device Model Number: 3280
• Device Catalogue Number: 3280
• Device Lot Number: 0032225914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 06/27/2024; 08/29/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/22/2024; 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 57 KG